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Routine Completion Angiography during Carotid Endarterectomy is not Mandatory
Eur J Vasc Endovasc Surg 32, 369e373 (2006) doi:10.1016/j.ejvs.2006.04.022, available online at http://www.sciencedirect.com on
Routine Completion Angiography during Carotid Endarterectomy is not Mandatory C. Pratesi, W. Dorigo, N. Troisi, A. Fargion, A.A. Innocenti, G. Pratesi, E. Barbanti and R. Pulli* Department of Vascular Surgery, University of Florence, Italy Objective. Intraoperative quality control after carotid endarterectomy (CEA) has been advocated to improve the results of surgical treatment of extracranial carotid artery disease. The aim of this study was to evaluate the usefulness of completion angiography (CA) in prevention of stroke and restenosis after CEA in a single center experience. Materials and methods. Data concerning 914 consecutive CEAs performed in 3 years (2000e2002) were prospectively collected in a dedicated database. Patients were divided into two groups: in the first group (mandatory-CA group; 430 cases) CA was routinely carried out, except in presence of contraindications to iodinate contrast agents; in the second group (selective-CA group, 484 cases) CA was performed only in selected cases, at surgeon’s discretion. Results. There were no significant differences between the two groups in terms of neurological complications at awakening (0.5% in mandatory-CA group and 0.4% in selective-CA group; p ¼ n.s.) and in 30-day stroke and death rate (1.9% and 1.4%, respectively; p ¼ n.s.). A surgical revision on the basis of CA findings was performed in 5 cases in mandatory-CA group and in 2 cases in selective-CA group (1.2% and 0.4%, respectively; p ¼ n.s.). In the second group, the conditions significantly associated with the need for CA examination were internal carotid near-occlusion, preoperative symptoms, shunt insertion, kind of surgical reconstruction, redo surgery. Estimated absence of ipsilateral stroke and absence of restenosis at 18 months was 98.9% and 89.7% in mandatory-CA group and 99.3% and 93.4% in selective-CA group (p ¼ n.s.) respectively. Conclusions. Based on our experience, routine CA following CEA is not suggested. A policy of selected CA at the surgeon’s discretion seems to make the intervention safe and durable as well. Keywords: Carotid endarterectomy; Completion angiography; Intraoperative quality control.
Introduction Carotid endarterectomy (CEA) is a safe and effective procedure and still represents the best therapeutic option1 for the treatment of extracranial carotid artery disease. Several strategies have been proposed to reduce perioperative complications and late ipsilateral neurological events2e5 including completion imaging. The aim of completion study after CEA is to identify potential technical defects or imperfections in the site of endarterectomy (intimal flaps, platelet aggregates, plaque residues, stenosing sutures, patch curves). These defects have been related to perioperative neurological complications6 and restenosis.7 Completion angiography (CA) was introduced in 1968 by Blaisdell8 to
achieve intraoperative quality control. In recent years duplex imaging9e11 and angioscopy12 have been proposed as alternative methods. The incidence of major technical defects reported in several studies varies between 5 and 43%,13 and because of different opinions concerning the need for treating these defects, there is no general agreement regarding either the need for performing routinely intraoperative control or the superiority of one method over the others. The aim of this study was to evaluate the effectiveness of completion angiography in prevention of early and late neurological complications and restenosis after CEA in a single center experience. Materials and Methods Patients
*Corresponding author. Dr. Raffaele Pulli, MD, Department of Vascular Surgery, University of Florence, Viale Morgagni 85, 50134 Florence, Italy. E-mail address: [email protected]
We prospectively collected in a dedicated database data concerning 914 consecutive CEAs performed
1078–5884/000369 + 05 $35.00/0 Ó 2006 Elsevier Ltd. All rights reserved.
370
C. Pratesi et al.
from January 2000 to December 2002 at our Department. Preoperative assessment consisted of computed tomography (CT) scan of cerebral parenchyma; double projection digital subtraction angiography (DSA) or computed tomography angiography (CTA) and duplex-scanning. Degree of stenosis was determined by mean of the NASCET method. Our strategy of intraoperative quality control substantially changed during the years and allowed us to create two different subgroups of patients. In the first group 430 CEAs carried out from January 2000 to June 2001 were included, and in the second group there were 484 CEAs performed between July 2001 and December 2002. In the first group (mandatoryCA group) completion angiography was routinely carried out, except in patients with history of allergic reactions to iodinate agents (11 cases) or elevate creatinine serum levels (37 cases) or monoclonal gammapathy (4 cases). In the second group (selective-CA group) completion angiography was performed only in selected cases when surgeon considered it necessary (48 cases).
Follow-up Follow-up clinical examination and duplex imaging were performed at 1, 3, 6, and 12 months and yearly thereafter. All studies were performed using the Acuson Sequoia 512 Ultrasound System (Acuson Corporation, Mountain View, Ca.), using a 8L5 linear array probe with an operating frequency of 8.0 5.0 MHz. Statistical analysis Statistical analysis was performed by means of SPSS 11.5 for Windows (SPSS Inc., Chicago, U.S.A.). General characteristics, vascular risk factors, intraoperative variables, perioperative risk of stroke and death and neurological morbidity rates in the two groups were analysed and compared by mean of c2 test or Fisher test when necessary. Statistical significance was defined at the p less than 0.05 level. Follow-up data were analysed by life-table analysis (Kaplan-Meier test) and results in subgroups were compared by means of log rank test.
Technical notes All the interventions were performed under general anaesthesia. Somatosensory evoked potentials (SEPs) were used to monitor cerebral status during surgical intervention and to indicate when shunt was necessary. A selective criterion for shunt insertion was used, defined as a reduction of N20/P25 waves lower than 75%.14 A selective policy of patching on the basis of sex, age and diameter of internal carotid artery was adopted. After standard CEA, performed in all the cases according to our technique of the early distal control of the internal carotid artery,15 all angiographic procedures were carried out under fluoroscopic control, using a mobile digital C-arm image intensifier. The CA after CEA was routinely performed using a standard procedure:16 at the end of the suture of the arteriotomy, after the clamps have been removed, a 21 gauge needle, connected to a syringe containing 10 ml of contrast medium, was introduced in the common carotid artery. Retrograde or anterograde injections were used, according to surgeons’ preferences. It was possible to obtain good visualization of intraand extracranial vessels in all the cases and the time necessary for the procedure was rarely longer than 5 minutes. Technical defects were defined as major flaws in the presence of residual stenosis >50% or dissection longer than 2 mm and minor flaws in the presence of residual stenosis <50% or short dissection. Eur J Vasc Endovasc Surg Vol 32, October 2006
Results The two groups were homogeneous for sex, age and traditional atherosclerotic risk factors, except for a slight prevalence of hyperlipemia in mandatory-CA group (Table 1). There were no differences between the two groups in terms of preoperative clinical status and degree of stenosis on operated side; also intraoperative technical features were similar (Table 2). In the mandatory-CA group there were 5 surgical revisions after CA, in 4 cases due to the presence of major technical flaws and in 1 case due to minor technical flaw; in selective-CA group there were 2 surgical revisions, both due to major flaws. Univariate analysis showed the presence of preoperative symptoms, the presence of internal carotid
Table 1. Demographic and risk factors for atherosclerosis in the two groups
Male sex Mean age Diabetes Coronary artery disease Hypercholesterolemia Hypertrigliceridemia Arterial hypertension Smoker or past smoker
Mandatory-CA group
Selective CA-group
p
300/430 (70%) 70.5 yrs. 106/430 (25%) 97/430 (22%) 195/430 (45%) 153/430 (35%) 290/430 (67%) 285/430 (66%)
340/484 (70%) 71.1 yrs. 92/484 (20%) 105/484 (21%) 171/484 (35%) 98/484 (20%) 332/484 (68%) 325/484 (67%)
n.s. n.s. n.s. n.s. 0.002 0.001 n.s. n.s.
371
Completion Angiography during Carotid Endarterectomy
Table 2. Preoperative clinical and anatomical status; intraoperative findings
Degree of stenosis - 50e70% - 70e80% - >80% - Near occlusion - Pseudo-occlusion Redo intervention
Mandatory-CA group
Selective CA-group
p
7/430 177/430 232/430 6/430 8/430
5/484 199/484 253/484 23/484 4/484
n.s. n.s. n.s. n.s.
(1.5%) (41%) (54%) (1.5%) (2%)
Neurological deficits at awake
(1%) (41%) (53%) (4%) (1%)
25/430 (6%)
23/484 (5%)
n.s.
Preoperative absence of symptoms
276/430 (64%)
278/454 (58%)
n.s.
Patch closure
312/430 (72%)
384/484 (78%)
n.s.
29/430 (7%) 15/430 (3.5%)
24/484 (5%) 17/484 (3.5%)
n.s. n.s.
5/430 (1%)
2/484 (0.5%)
n.s.
Shunt insertion - SEPs reduction - Routine shunt Surgical revision
Table 4. Early results
30 day results - minor stroke - major stroke - deaths 30-day stroke and death rate
Mandatory-CA group
Selective-CA group
p
2/430 (0.5%)
2/484 (0.4%)
n.s.
0 5/430 (1.1%) 3/430 (0.7%)
4/484 (0.8%) 0 3/484 (0.6%)
n.s. n.s. n.s.
8/430 (1.8%)
7/484 (1.4%)
n.s.
6.6%, respectively; p ¼ 0.6 log rank 0.22; Fig. 2). No significant difference in restenosis rate were found in patients with or without surgical revisions. Discussion
Table 3. Univariate analysis for the need of completion CA in selective-CA group
1,0 0,9 0,8 m-CA group 98.9% s-CA group 99.3%
0,7 0,6
p = n.s.
0,5 0,4 0,3 0,2 0,1 0,0
p
Selective-CA - shunt insertion - no shunt insertion
10/41 (24%) 38/443 (8.5%)
-
5/10 4/85 36/384 3/15
eversion CEA primary closure patch closure carotid bypass
Previous studies6,8,11,17e22 (Table 2) show that technical defects or imperfections during carotid surgery are not infrequent. In Blaisdell’s experience,8 CA revealed significant lesions in 26% of the cases. Several authors23,24 report significant improvement in the results of CEA for patients undergoing completion angiography. Despite these results, the usefulness of
absence of ipsilateral stroke
near-occlusion, the kind of arterial reconstruction, shunt insertion and redo interventions to be significantly associated to the choice of performing CA in selective-CA group (Table 3). Neurological complications on waking and at 30days did not significantly differ in both groups (Table 4). Follow-up was performed in 853 patients (93.3%), with a median duration of 12 months (range 1e34). During follow-up there were 6 deaths and 5 neurological events ipsilateral to operated carotid artery (2 transient ischemic attacks and 3 major strokes); no contralateral neurological deficits were detected. Estimated cumulative 18 months-survival was 97.1% in mandatory-CA group and 99.2% in selectiveCA group ( p ¼ 0.07; log-rank 3.4). Estimated absence of ipsilateral stroke at 18 months was 98.9% in the first group and 99.3% in the second group ( p ¼ 0.9; log-rank 0; Fig. 1) and estimated restenosis >50% rate at 18 months was similar in the two groups (10.3% and
0
12
0.005
(50%) (4.7%) (9.5%) (20%)
<0.001
- carotid near-occlusion - no carotid near occlusion
11/23 (48%) 38/443 (8.5%)
<0.001
- symptomatic patients - asymptomatic patients
29/206 (14%) 19/278 (7%)
0.008
- primary intervention - redo surgery
38/462 (8%) 10/22 (45%)
<0.001
24
months 0
months mandatory-CA group
6
12
18
387
274
117
73
463
231
78
31
(number at risk) selective-CA group (number at risk)
Fig. 1. Estimated absence of ipsilateral stroke at 18 months. Eur J Vasc Endovasc Surg Vol 32, October 2006
372
C. Pratesi et al.
particularly when the distal end-point has not been clearly visualised for example during eversion endarterectomy.19,25 Other situations in which CA should be considered are primary closure,29 after CEA performed for carotid near-occlusion30 and after redo carotid surgery. In our opinion, in patients who have shunt insertion and in the presence of reinterventions or carotid near-occlusion, completion angiography is worthwhile. Moreover, when the surgeon uses a technique which he is not familial with (in our experience eversion CEA and carotid bypass), CA is suggested. In conclusion, data from our experience suggest that routine CA following CEA is not justified. CA may be useful for less experienced surgeons or in difficult cases at the surgeon’s discretion.
absence of severe restenosis
1,0
0,8 m-CA group 89.7% s-CA group 93.4% 0,6 p = n.s. 0,4
0,2
0,0 0
12
24
months months
0
6
12
18
mandatory-CA group
387
274
117
73
463
232
78
31
(number at risk) selective-CA group (number at risk)
Fig. 2. Estimated absence of severe restenosis at 18 months.
an intraoperative quality control during extracranial carotid surgery remains an unresolved problem and there is no strong evidence to support its routine application. The main reason for this doubt is related to the still undemonstrated correlation between technical defects or imperfections and neurological events in the early postoperative period. Several authors19,25 deny the effectiveness of completion imaging, supposing that few lesions require immediate surgical revision. Intraoperative completion angiography is a safe procedure. Allergic reactions are rarely described26 and the radiological risk to the surgeon is low.27 It has been hypothesized that 20,000 intra-operative angiograms are necessary to expose the surgeon to a cumulative dose of dangerous radiations. In recent years, the use duplex scanning has been proposed as an alternative or adjunctive method for intraoperative completion imaging. In the detection of minor technical defects after CEA,28 duplex scanning has been reported to be more accurate than carotid angiography. On the basis of our findings, routine CA is not justified. We suggest selective intraoperative angiography, Eur J Vasc Endovasc Surg Vol 32, October 2006
References 1 BOND R, RERKASEM K, ROTHWELL PM. Systematic review of the risks of carotid endarterectomy in relation to the clinical indication for and timing of surgery. Stroke 2003;34:2290e2301. 2 TESO D, FRATTINI JC, DARDIK A. Improved outcomes of carotid endarterectomy: the critical role of vascular surgeons. Semin Vasc Surg 2004;17:214e218. 3 CUNNINGHAM EJ, BOND R, MEHTA Z, MAYBERG MR, WARLOW CP, ROTHWELL PM. European Carotid Surgery Trialists’ Collaborative Group. Long-term durability of carotid endarterectomy for symptomatic stenosis and risk factors for late postoperative stroke. Stroke 2002;33:2658e2663. 4 PEDRINI L, TARANTINI S, CIRELLI MR, BALLESTER A, CIFIELLO BI, D’ADDATO M. Intraoperative assessment of cerebral ischaemia during carotid surgery. Int Angiol 1998;17:10e14. 5 BOND R, RERKASEM K, ABURAHMA AF, NAYLOR AR, ROTHWELL PM. Patch angioplasty versus primary closure for carotid endarterectomy. Cochrane Database Syst Rev 2004;2:CD000160. 6 DONALDSON MC, IVARSSON B, MANICK J, WHITTEMORE AD. Impact of completion angiography on operative conduct and results of carotid endarterectomy. Ann Surg 1993;6:682e687. 7 KINNEY EV, SEABROOKE G, KINNEY LY, BANDYK DF, TOWNE JB. The importance of intra-operative detection of residual flow abnormalities after carotid endarterectomy. J Vasc Surg 1993; 17:912e922. 8 BLAISDELL FW, LIM R, HALL AD. Technical results of carotid endarterectomy: arteriographic assement. Am J Surg 1967;114: 239e246. 9 GOLLEDGE J, CUMING R, ELLIS M, DAVIES AH, GREENHALGH RM. Duplex imaging findings predict stenosis after carotid endarterectomy. J Vasc Surg 1997;26:43e48. 10 WALKER RA, FOX AD, MAGEE TR, HORROCKS M. Intraoperative duplex scanning as a means of quality control during carotid endarterectomy. Eur J Vasc Endovasc Surg 1996;11:364e367. 11 VALENTI D, GAGGIANO A, BERARDI G, FERRI M, MAZZEI R, RODA G et al. Intra-operative assessment of technical defects after carotid endarterectomy: a comparison between angiography and colour duplex scan. Cardiovasc Surg 2003;11:26e29. 12 GAUNT ME, SMITH JL, RATLIFF DA, BELL PR, NAYLOR AR. A comparison of quality control methods applied to carotid endarterectomy. Eur J Vasc Endovasc Surg 1996;11:4e11. 13 GASPAR MR, AVERBROOK AW. Intraoperative assessment of the technical results of carotid endarterectomy: angiography. In: MOORE W, ed. Surgery for cerebrovascular disease. Philadelphia: WB Saunders; 1996:393e402. 14 PULLI R, DORIGO W, BARBANTI E, AZAS L, RUSSO D, MATTICARI S et al. Carotid endarterectomy with contralateral carotid artery
Completion Angiography during Carotid Endarterectomy
15
16
17 18 19 20 21
22
occlusion: is this a higher risk subgroup? Eur J Vasc Endovasc Surg 2002;24:63e68. PRATESI C, DORIGO W, INNOCENTI AA, AZAS L, BARBANTI E, LOMBARDI R et al. Reducing the risk of intraoperative neurological complications during carotid endarterectomy with early distal control of the internal carotid artery. Eur J Vasc Endovasc Surg 2004;28:670e673. BERTINI D, GATTI M, PRATESI C. Controllo intraoperatorio del paziente operato di tromboendarterectomia carotidea. In: D’ADDATO M, BRACALE GC, ODERO A, SPARTERA C, STELLA A, eds. Il follow-up in chirurgia vascolare. Torino: Edizioni Minerva Medica; 1998:413e423. ANDERSEN CA, COLLINS GJ, RICH NM. Routine operative angiography during carotid endarterectomy: a reassessment. Surgery 1978;83:67e71. ZIERLER RE, BANDYK DF, THIELE BL. Intraoperative assessment of carotid endarterectomy. J Vasc Surg 1984;1:73e83. RICOTTA JJ, O’BRIEN-IRR MS. Completion angiography, is it really necessary? Am J Surg 1997;174:181e184. WESTERBAND A, MILLS JL, BERMAN SS, HUNTER GC. The influence of routine completion arteriography on outcome following carotid endarterectomy. Ann Vasc Surg 1997;11:14e19. ZANNETTI S, CAO PP, DE RANGO P, GIORDANO G, PARLANI G, LENTI M et al. Intraoperative assessment of technical perfection in carotid endarterectomy: a prospective analysis of 1305 completion procedures. Collaborators of the EVEREST study group. Eversion versus standard carotid endartectomy. Eur J Vasc Endovasc Surg 1999;18:52e58. WOELFLE KD, BRUIJNEN H, NEU J, CAMPBELL P, WACK C, LOEPRECHT H. The role of intraoperative digital subtraction
23 24
25 26 27 28 29
30
373
angiography for quality control of standard carotid endarterectomy using patch angioplasty. Cardiovasc Surg 2002;10:116e122. ROON AJ, HOOGERWERF D. Intraoperative arteriography and carotid surgery. J Vasc Surg 1992;16:239e243. COURBIER R, JAUSSERAN J, REGGI M, BERGERON P, FORMICHI M, FERDANI M. Routine intraoperative carotid angiography: its impact on operative morbidity and carotid restenosis. J Vasc Surg 1986;3:343e350. JAIN KM, SIMONI EJ, MUNN JS. Routine completion study during carotid endarterectomy is not necessary. Am J Surg 1994;168: 163e167. COCHRAN ST. Anaphylactoid reactions to radiocontrast media. Curr Allergy Asthma Rep 2005;5:28e31. RAMALANJAONA GR, PEARCE WH, RITENOUR ER. Radiation exposure risk to the surgeon during operative angiography. J Vasc Surg 1986;4:224e228. WALKER RA, FOX AD, MAGEE TR, HORROCKS M. Intraoperative duplex scanning as a means of quality control during carotid endarterectomy. Eur J Vasc Endovasc Surg 1996;11:364e367. LOHR JM, ALBERS B, ROAT TW, BYRNE MP, ROEDERSHEIMER LR, PIERCEFIELD GG. Effects of completion angiography on the outcome of carotid endarterectomy. Cardiovasc Surg 1995;3: 299e305. PULLI R, FROSINI P, GATTI M, NARCETTI S, BERNACCHI R, PRATESI C. Internal carotid pseudo-occlusion: early and late results. J Cardiovasc Surg 1997;38:15e20.
Accepted 15 April 2006 Available online 13 June 2006
Eur J Vasc Endovasc Surg Vol 32, October 2006
Routine Completion Angiography during Carotid Endarterectomy is not Mandatory C. Pratesi, W. Dorigo, N. Troisi, A. Fargion, A.A. Innocenti, G. Pratesi, E. Barbanti and R. Pulli* Department of Vascular Surgery, University of Florence, Italy Objective. Intraoperative quality control after carotid endarterectomy (CEA) has been advocated to improve the results of surgical treatment of extracranial carotid artery disease. The aim of this study was to evaluate the usefulness of completion angiography (CA) in prevention of stroke and restenosis after CEA in a single center experience. Materials and methods. Data concerning 914 consecutive CEAs performed in 3 years (2000e2002) were prospectively collected in a dedicated database. Patients were divided into two groups: in the first group (mandatory-CA group; 430 cases) CA was routinely carried out, except in presence of contraindications to iodinate contrast agents; in the second group (selective-CA group, 484 cases) CA was performed only in selected cases, at surgeon’s discretion. Results. There were no significant differences between the two groups in terms of neurological complications at awakening (0.5% in mandatory-CA group and 0.4% in selective-CA group; p ¼ n.s.) and in 30-day stroke and death rate (1.9% and 1.4%, respectively; p ¼ n.s.). A surgical revision on the basis of CA findings was performed in 5 cases in mandatory-CA group and in 2 cases in selective-CA group (1.2% and 0.4%, respectively; p ¼ n.s.). In the second group, the conditions significantly associated with the need for CA examination were internal carotid near-occlusion, preoperative symptoms, shunt insertion, kind of surgical reconstruction, redo surgery. Estimated absence of ipsilateral stroke and absence of restenosis at 18 months was 98.9% and 89.7% in mandatory-CA group and 99.3% and 93.4% in selective-CA group (p ¼ n.s.) respectively. Conclusions. Based on our experience, routine CA following CEA is not suggested. A policy of selected CA at the surgeon’s discretion seems to make the intervention safe and durable as well. Keywords: Carotid endarterectomy; Completion angiography; Intraoperative quality control.
Introduction Carotid endarterectomy (CEA) is a safe and effective procedure and still represents the best therapeutic option1 for the treatment of extracranial carotid artery disease. Several strategies have been proposed to reduce perioperative complications and late ipsilateral neurological events2e5 including completion imaging. The aim of completion study after CEA is to identify potential technical defects or imperfections in the site of endarterectomy (intimal flaps, platelet aggregates, plaque residues, stenosing sutures, patch curves). These defects have been related to perioperative neurological complications6 and restenosis.7 Completion angiography (CA) was introduced in 1968 by Blaisdell8 to
achieve intraoperative quality control. In recent years duplex imaging9e11 and angioscopy12 have been proposed as alternative methods. The incidence of major technical defects reported in several studies varies between 5 and 43%,13 and because of different opinions concerning the need for treating these defects, there is no general agreement regarding either the need for performing routinely intraoperative control or the superiority of one method over the others. The aim of this study was to evaluate the effectiveness of completion angiography in prevention of early and late neurological complications and restenosis after CEA in a single center experience. Materials and Methods Patients
*Corresponding author. Dr. Raffaele Pulli, MD, Department of Vascular Surgery, University of Florence, Viale Morgagni 85, 50134 Florence, Italy. E-mail address: [email protected]
We prospectively collected in a dedicated database data concerning 914 consecutive CEAs performed
1078–5884/000369 + 05 $35.00/0 Ó 2006 Elsevier Ltd. All rights reserved.
370
C. Pratesi et al.
from January 2000 to December 2002 at our Department. Preoperative assessment consisted of computed tomography (CT) scan of cerebral parenchyma; double projection digital subtraction angiography (DSA) or computed tomography angiography (CTA) and duplex-scanning. Degree of stenosis was determined by mean of the NASCET method. Our strategy of intraoperative quality control substantially changed during the years and allowed us to create two different subgroups of patients. In the first group 430 CEAs carried out from January 2000 to June 2001 were included, and in the second group there were 484 CEAs performed between July 2001 and December 2002. In the first group (mandatoryCA group) completion angiography was routinely carried out, except in patients with history of allergic reactions to iodinate agents (11 cases) or elevate creatinine serum levels (37 cases) or monoclonal gammapathy (4 cases). In the second group (selective-CA group) completion angiography was performed only in selected cases when surgeon considered it necessary (48 cases).
Follow-up Follow-up clinical examination and duplex imaging were performed at 1, 3, 6, and 12 months and yearly thereafter. All studies were performed using the Acuson Sequoia 512 Ultrasound System (Acuson Corporation, Mountain View, Ca.), using a 8L5 linear array probe with an operating frequency of 8.0 5.0 MHz. Statistical analysis Statistical analysis was performed by means of SPSS 11.5 for Windows (SPSS Inc., Chicago, U.S.A.). General characteristics, vascular risk factors, intraoperative variables, perioperative risk of stroke and death and neurological morbidity rates in the two groups were analysed and compared by mean of c2 test or Fisher test when necessary. Statistical significance was defined at the p less than 0.05 level. Follow-up data were analysed by life-table analysis (Kaplan-Meier test) and results in subgroups were compared by means of log rank test.
Technical notes All the interventions were performed under general anaesthesia. Somatosensory evoked potentials (SEPs) were used to monitor cerebral status during surgical intervention and to indicate when shunt was necessary. A selective criterion for shunt insertion was used, defined as a reduction of N20/P25 waves lower than 75%.14 A selective policy of patching on the basis of sex, age and diameter of internal carotid artery was adopted. After standard CEA, performed in all the cases according to our technique of the early distal control of the internal carotid artery,15 all angiographic procedures were carried out under fluoroscopic control, using a mobile digital C-arm image intensifier. The CA after CEA was routinely performed using a standard procedure:16 at the end of the suture of the arteriotomy, after the clamps have been removed, a 21 gauge needle, connected to a syringe containing 10 ml of contrast medium, was introduced in the common carotid artery. Retrograde or anterograde injections were used, according to surgeons’ preferences. It was possible to obtain good visualization of intraand extracranial vessels in all the cases and the time necessary for the procedure was rarely longer than 5 minutes. Technical defects were defined as major flaws in the presence of residual stenosis >50% or dissection longer than 2 mm and minor flaws in the presence of residual stenosis <50% or short dissection. Eur J Vasc Endovasc Surg Vol 32, October 2006
Results The two groups were homogeneous for sex, age and traditional atherosclerotic risk factors, except for a slight prevalence of hyperlipemia in mandatory-CA group (Table 1). There were no differences between the two groups in terms of preoperative clinical status and degree of stenosis on operated side; also intraoperative technical features were similar (Table 2). In the mandatory-CA group there were 5 surgical revisions after CA, in 4 cases due to the presence of major technical flaws and in 1 case due to minor technical flaw; in selective-CA group there were 2 surgical revisions, both due to major flaws. Univariate analysis showed the presence of preoperative symptoms, the presence of internal carotid
Table 1. Demographic and risk factors for atherosclerosis in the two groups
Male sex Mean age Diabetes Coronary artery disease Hypercholesterolemia Hypertrigliceridemia Arterial hypertension Smoker or past smoker
Mandatory-CA group
Selective CA-group
p
300/430 (70%) 70.5 yrs. 106/430 (25%) 97/430 (22%) 195/430 (45%) 153/430 (35%) 290/430 (67%) 285/430 (66%)
340/484 (70%) 71.1 yrs. 92/484 (20%) 105/484 (21%) 171/484 (35%) 98/484 (20%) 332/484 (68%) 325/484 (67%)
n.s. n.s. n.s. n.s. 0.002 0.001 n.s. n.s.
371
Completion Angiography during Carotid Endarterectomy
Table 2. Preoperative clinical and anatomical status; intraoperative findings
Degree of stenosis - 50e70% - 70e80% - >80% - Near occlusion - Pseudo-occlusion Redo intervention
Mandatory-CA group
Selective CA-group
p
7/430 177/430 232/430 6/430 8/430
5/484 199/484 253/484 23/484 4/484
n.s. n.s. n.s. n.s.
(1.5%) (41%) (54%) (1.5%) (2%)
Neurological deficits at awake
(1%) (41%) (53%) (4%) (1%)
25/430 (6%)
23/484 (5%)
n.s.
Preoperative absence of symptoms
276/430 (64%)
278/454 (58%)
n.s.
Patch closure
312/430 (72%)
384/484 (78%)
n.s.
29/430 (7%) 15/430 (3.5%)
24/484 (5%) 17/484 (3.5%)
n.s. n.s.
5/430 (1%)
2/484 (0.5%)
n.s.
Shunt insertion - SEPs reduction - Routine shunt Surgical revision
Table 4. Early results
30 day results - minor stroke - major stroke - deaths 30-day stroke and death rate
Mandatory-CA group
Selective-CA group
p
2/430 (0.5%)
2/484 (0.4%)
n.s.
0 5/430 (1.1%) 3/430 (0.7%)
4/484 (0.8%) 0 3/484 (0.6%)
n.s. n.s. n.s.
8/430 (1.8%)
7/484 (1.4%)
n.s.
6.6%, respectively; p ¼ 0.6 log rank 0.22; Fig. 2). No significant difference in restenosis rate were found in patients with or without surgical revisions. Discussion
Table 3. Univariate analysis for the need of completion CA in selective-CA group
1,0 0,9 0,8 m-CA group 98.9% s-CA group 99.3%
0,7 0,6
p = n.s.
0,5 0,4 0,3 0,2 0,1 0,0
p
Selective-CA - shunt insertion - no shunt insertion
10/41 (24%) 38/443 (8.5%)
-
5/10 4/85 36/384 3/15
eversion CEA primary closure patch closure carotid bypass
Previous studies6,8,11,17e22 (Table 2) show that technical defects or imperfections during carotid surgery are not infrequent. In Blaisdell’s experience,8 CA revealed significant lesions in 26% of the cases. Several authors23,24 report significant improvement in the results of CEA for patients undergoing completion angiography. Despite these results, the usefulness of
absence of ipsilateral stroke
near-occlusion, the kind of arterial reconstruction, shunt insertion and redo interventions to be significantly associated to the choice of performing CA in selective-CA group (Table 3). Neurological complications on waking and at 30days did not significantly differ in both groups (Table 4). Follow-up was performed in 853 patients (93.3%), with a median duration of 12 months (range 1e34). During follow-up there were 6 deaths and 5 neurological events ipsilateral to operated carotid artery (2 transient ischemic attacks and 3 major strokes); no contralateral neurological deficits were detected. Estimated cumulative 18 months-survival was 97.1% in mandatory-CA group and 99.2% in selectiveCA group ( p ¼ 0.07; log-rank 3.4). Estimated absence of ipsilateral stroke at 18 months was 98.9% in the first group and 99.3% in the second group ( p ¼ 0.9; log-rank 0; Fig. 1) and estimated restenosis >50% rate at 18 months was similar in the two groups (10.3% and
0
12
0.005
(50%) (4.7%) (9.5%) (20%)
<0.001
- carotid near-occlusion - no carotid near occlusion
11/23 (48%) 38/443 (8.5%)
<0.001
- symptomatic patients - asymptomatic patients
29/206 (14%) 19/278 (7%)
0.008
- primary intervention - redo surgery
38/462 (8%) 10/22 (45%)
<0.001
24
months 0
months mandatory-CA group
6
12
18
387
274
117
73
463
231
78
31
(number at risk) selective-CA group (number at risk)
Fig. 1. Estimated absence of ipsilateral stroke at 18 months. Eur J Vasc Endovasc Surg Vol 32, October 2006
372
C. Pratesi et al.
particularly when the distal end-point has not been clearly visualised for example during eversion endarterectomy.19,25 Other situations in which CA should be considered are primary closure,29 after CEA performed for carotid near-occlusion30 and after redo carotid surgery. In our opinion, in patients who have shunt insertion and in the presence of reinterventions or carotid near-occlusion, completion angiography is worthwhile. Moreover, when the surgeon uses a technique which he is not familial with (in our experience eversion CEA and carotid bypass), CA is suggested. In conclusion, data from our experience suggest that routine CA following CEA is not justified. CA may be useful for less experienced surgeons or in difficult cases at the surgeon’s discretion.
absence of severe restenosis
1,0
0,8 m-CA group 89.7% s-CA group 93.4% 0,6 p = n.s. 0,4
0,2
0,0 0
12
24
months months
0
6
12
18
mandatory-CA group
387
274
117
73
463
232
78
31
(number at risk) selective-CA group (number at risk)
Fig. 2. Estimated absence of severe restenosis at 18 months.
an intraoperative quality control during extracranial carotid surgery remains an unresolved problem and there is no strong evidence to support its routine application. The main reason for this doubt is related to the still undemonstrated correlation between technical defects or imperfections and neurological events in the early postoperative period. Several authors19,25 deny the effectiveness of completion imaging, supposing that few lesions require immediate surgical revision. Intraoperative completion angiography is a safe procedure. Allergic reactions are rarely described26 and the radiological risk to the surgeon is low.27 It has been hypothesized that 20,000 intra-operative angiograms are necessary to expose the surgeon to a cumulative dose of dangerous radiations. In recent years, the use duplex scanning has been proposed as an alternative or adjunctive method for intraoperative completion imaging. In the detection of minor technical defects after CEA,28 duplex scanning has been reported to be more accurate than carotid angiography. On the basis of our findings, routine CA is not justified. We suggest selective intraoperative angiography, Eur J Vasc Endovasc Surg Vol 32, October 2006
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Accepted 15 April 2006 Available online 13 June 2006
Eur J Vasc Endovasc Surg Vol 32, October 2006